Rooted in Gujarat, yet focussed on the globe. With its plasma
protein initiative, Intas Biopharmaceuticals displays a savvy business sense
by entering a less attractive but potentially lucrative segment. Suja Nair
traces their journey

"Celestial
is the only player in India, which sources plasma from various blood banks
in India, and obtains fractionated plasma proteins through a contractual
arrangement"

- Dr Urmish Chudgar
Managing Director
IBPL

Incorporated by Hasmukh Chudgar in 1976, Intas Biopharmaceuticals
Limited (IBPL) has come a long way. From a small unit at Vatva, near Ahmedabad,
IBPL entered mainstream pharma market, showing consistent growth over the years.
Since the launch of biotechnology operations in May 2000, R&D and manufacturing
of biopharmaceutical products, with a special focus on oncology, have been major
thrust areas for the company. According to Dr Urmish Chudgar, Managing Director,
IBPL, "Starting with bio-generics, IBPL has structured its progression
to the development of proprietary and innovative recombinant biopharmaceuticals.
IBPL derives its competitive edge from successful and strategic moves it has
made in the areas of R&D, manufacturing, marketing and global operations."
The company has successfully launched bio-similar products like Neukine (rHu
G-CSF), Erykine and Epofit (rHu EPO), Intalfa (rHu IFN Alfa-2b), and Neupeg
(Pegylated rHu G-CSF). According to Mani Iyer, Executive Director, IBPL, "Our
bottom line sales have been strong throughout past fiscal. With the launch of
Neupeg (Peg Filgrastim), we have gained monopoly in the domestic market in terms
of being sole manufacturers of Peg Filgrastim in India. With an array of oncology
products and new sales strategy in place for current fiscal, we are looking
to grab major market share in the oncology segment."

Highlights

"Its
potent combination of pioneering vision, entrepreneurial spirit, sound infrastructure
and ability to adapt to changing times have helped shape Gujarat as a pharma
hub"

- Mani Iyer
Executive Director
IBPL

As per ORG IMS report of May 2007, IBPL is amongst the top
20 players in the Indian pharma industry. IBPL is present in South East-Asia
and the African continent. Further, with its European venture, the company has
also consolidated its position in international markets. Its manufacturing
unit at Matoda, on the outskirts of Ahmedabad, is rated as one of the best in
the Asia-Pacific region, for cytotoxic products with barrier isolation technology.
The facility complies with strict international good manufacturing practice
(GMP) regulations and has also received the European Union-Good Manufacturing
Practice (EU-GMP) and conforms to guidelines laid down by World Health Organization
(WHO).

The company has a oncology product basket catering to solid
tumours, haematological malignancies and supportive therapies. On the R&D
front, IBPL has significant presence in North America with an agreement and
MoU with two technology companies. In January 2007, the company committed Rs
13 crore towards conducting clinical trials and producing Factor IX, used for
treatment of haemophilia B, through novel transgenic platform. Thereafter, IBPL
inked an MoU with Canada-based Viropro for co-development of a novel molecule.

Branching out

IBPL’s facility at Moraiya, 22 kms from Ahmedabad

IBPL has a number of subsidiaries through which it functions;
one of them is Indus Biotherapeutics, which is a biopharmaceutical contract
research organisation that solely concentrates on research and development of
novel targets as well as bio-generics. Another subsidiary that is associated
with the company is Celestial Biologicals, which focuses on manufacturing and
marketing of plasma-derived products. The company has commenced marketing of
plasma proteinsalbumin and immunoglobulins (IVIG)under the brand
names of 'Albucel' and 'Globucel' respectively in the Indian market, and has
plans to expand its product portfolio. Chudgar adds, "Celestial is the
only player in India, which sources plasma from various blood banks in India,
and obtains fractionated plasma proteins through a contractual arrangement.
There are plans to invest heavily in South Asia's largest plasma fractionation
facility, which is focused on being able to offer fractionation services to
South Asian nations, apart from India."

Looking ahead

The company is set to tap emerging opportunities in active biologic ingredients
(ABIs) and bio-generics market. The company has also entered several supply
and marketing agreements with reputed international companies in regulated and
semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia and CIS,
South and Central America and Africa. Currently, the company is executing contract
research and manufacturing agreements (CRAMS) for a European client for development,
scale-up and commercial supply of a novel bio-therapeutic protein. Iyer informs,
"We are planning to generate clones for commercial production of protein
using state-of-the-art technologies to improve yields, quality, as well as adopting
novel expression systems (including transgenics) with an objective to build
intellectual property (IP) over the long run. IBPL, in a planned and phase-wise
manner, will screen technologies/new molecules and identify the most promising
ones, prioritising them on the basis of their business potential and compatibility."
On the same lines, he says that this area has strong potential for generating
IP in terms of patents and publications and could provide a novel platform for
delivery of many protein therapeutics.

Listing Gujarats achievement over the past century, Iyer says "Gujarat
was the first to manufacture APIs and finished dosage form in India, manufacture
pharmaceutical machinery, lead the way with clinical research organisations
and become the first to undertake pre-clinical safety and toxicology studies
in the country. Strong linkages between SME players, industrial bodies and medical
and financial institutions have created a proper ecosystem for growth of pharma/biotech
industry in the state. Its potent combination of pioneering vision, entrepreneurial
spirit, sound infrastructure and ability to adapt to changing times have helped
shape Gujarat as a pharma hub." He further said that in future, Gujarat
has potential to capitalise on SEZ-led exports, as well as the fast growing
CRAMS and R&D biogeneric segments.

On Government initiatives, Iyers avers that central Government bodies including
Department of Science and Technology (DST) and Department of Biotechnology (DBT)
have played a major role in extending benefits to biotechnology companies by
means of fiscal incentives, special grants and other tax-friendly measures.
He also mentions that the Government has made an important contribution towards
strengthening regulatory framework and Intellectual Property Rights (IPR) issues.
They have significantly helped in development of skilled resources in terms
of academic institutes and educational base as well as increased allocation
of funds with an emphasis on R&D. However, he adds that the Government can
certainly take more steps to improve. For instance, the SME and middle size
pharma/biotech companies should have access to more financing opportunities
from Government in the form of venture capital which will encourage entrepreneurs.
Further he concludes, "The state's approach to biotech development is reflected
from the fact that the new Biotechnology Policy has major focus on promoting
biotech research and extending support in the form of incentives, concessions
and benefits to new players."